Ready to Use Supplementary Food in Moderate Childhood Malnutrition

January 23, 2012 updated by: Medecins Sans Frontieres, Netherlands

Effectiveness of a Ready-to-Use-Supplementary-Food for the Treatment of Moderate Childhood Malnutrition

Since 2001, Ready to Use Therapeutic Foods (RUTF) are widely used to treat severe malnutrition. Their efficacy and effectiveness were proven in community therapeutic care programs. Recently, the question rose if RUTF would be more effective than enriched flours to treat moderate malnutrition.

The purpose of this study is to compare the effectiveness of Ready to Use Food Supplementary-plumpy® and Premix Corn Soy Blend with oil in term of cure rate, weight gain, duration of treatment, morbidity and mortality in the treatment of moderate acute malnutrition.

Compare the longer term effect on nutritional status and morbidity (relapse?).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

570

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sierra Leone
      • Bo, Sierra Leone
        • Health Centers run by MSF and MOH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 5 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • all children aged 6 months to 5 years admitted to SFC outpatient care during the study period
  • WHM between 70-79% (1977 NCHS/WHO standard) without edema
  • approval from the caretaker

Exclusion Criteria:

  • presence of the following signs: bilateral edema, MUAC<110 mm , WHM< 70%(criteria for severe malnutrition), and medical complications necessitating hospitalisation
  • refusal to participate from caretaker

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Ready to Use Supplementary Food
Ready to Use Supplementary Food treatment
Dietary supplement: Ready to Use Supplementary Food
Children received two Supplementary-plumpy® packages per day (184g) providing 1000 Kcal, 26g (10.4%) protein, 68g (61.2%) fat, and 100% of micronutrient requirements based on the Daily Recommended Nutrient Intake.
Other Names:
  • Supplementary-plumpy®
ACTIVE_COMPARATOR: Premix
Premix Corn Soy Blend-oil treatment
Dietary supplement: Premix CSB-oil treatment
Children received 2 kg of premix per week (226g CSB, 37g oil, and 23g sugar / day) providing 1277 Kcal, 40.7g protein (12.7%), 50.6g (35.7%) fat, and 100% of micronutrient according to the DRNI guidelines
Other Names:
  • Corn Soy Blend
  • Fortified Blended Flours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recovery
Time Frame: 112 days
proportion of children who recovered, defined as WHM> 85% for two consecutive weeks
112 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
average weight gain
Time Frame: 112 days
in g per kg of weight per day
112 days
Duration of treatment
Time Frame: 112 days
average length of stay in days.
112 days
Morbidity
Time Frame: 11 months
number of morbidity episodes during the treatment and six months thereafter
11 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medecins Sans Frontieres, Netherlands

Collaborators

London School of Hygiene and Tropical Medicine
United Nations World Food Programme (WFP)
Nutriset

Investigators

  • Principal Investigator: Pascale Delchevalerie, Msc, Medecins Sans Frontieres, Netherlands

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (ACTUAL)

August 1, 2007

Study Completion (ACTUAL)

April 1, 2008

Study Registration Dates

First Submitted

June 17, 2010

First Submitted That Met QC Criteria

June 17, 2010

First Posted (ESTIMATE)

June 22, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

January 24, 2012

Last Update Submitted That Met QC Criteria

January 23, 2012

Last Verified

March 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSFOCB1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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